KR950702811A - Printed Transdermal Drug Delivery Device - Google Patents

Printed Transdermal Drug Delivery Device Download PDF

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Publication number
KR950702811A
KR950702811A KR1019950700729A KR19950700729A KR950702811A KR 950702811 A KR950702811 A KR 950702811A KR 1019950700729 A KR1019950700729 A KR 1019950700729A KR 19950700729 A KR19950700729 A KR 19950700729A KR 950702811 A KR950702811 A KR 950702811A
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South Korea
Prior art keywords
nicotine
patient
hours
adhesive layer
contact
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KR1019950700729A
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Korean (ko)
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미란다 지저스
더블유. 클레어리 게리
Original Assignee
더블유. 클레어리 게리
시그너스 세라퓨틱 시스템스(Cygnus Therapeutic Systems)
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Publication of KR950702811A publication Critical patent/KR950702811A/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/465—Nicotine; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
    • A61K9/7084—Transdermal patches having a drug layer or reservoir, and one or more separate drug-free skin-adhesive layers, e.g. between drug reservoir and skin, or surrounding the drug reservoir; Liquid-filled reservoir patches

Abstract

24시간동안 사람환자에 의해 착용될 수 있고 대략 16시간동안 환자에게 약제를 계속적으로 투여하는 경피약제추여장치가 특정제조방법에 의해 생성된다. 이 장치는 24시간동안 투여된다면 약제내성(가령, 니트로글리세린) 또는 수면장애(가령, 니코틴) 같은 문제를 야기하는 약제의 투여에 관하여 특히 유용하다. 대략 16시간후에는 환자에 대한 약제의 약리학적 효과가 실질적으로 존재하지 않게 되는 정도까지 환자에의 약제투여속도가 느려지는 정도로 장치로부티 약제가 고갈될 농도로 약제가 장치속에 로딩된다.Transdermal drug delivery devices that can be worn by human patients for 24 hours and that continue to administer the drug to the patient for approximately 16 hours are created by specific manufacturing methods. This device is particularly useful with regard to the administration of a medicament which, if administered for 24 hours, causes problems such as drug resistance (eg nitroglycerin) or sleep disorders (eg nicotine). After approximately 16 hours, the drug is loaded into the device at a concentration at which the device will be depleted into the device such that the rate of drug administration to the patient is slowed down to the extent that the drug's pharmacological effect on the patient is substantially absent.

Description

프린트 경피약제투여장치(Printed Transdermal Drug Delivery Device)Printed Transdermal Drug Delivery Device

본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음Since this is an open matter, no full text was included.

제1도는 본 발명에 따른 경피약제 투여장치의 부분단면도를 나타낸다.1 is a partial cross-sectional view of a transdermal drug administration device according to the present invention.

제2도는 본 발명의 방법에 따라 경피약제 투여장치를 제조하는데 사용할 수 있는 장치를 나타낸다.2 shows a device that can be used to prepare a transdermal drug administration device according to the method of the present invention.

제3도는 본 발명에서 개시된 방법에 따라 제조한 경피약제 투어장치로부터 사람시체 피부를 통한 니코틴의 생체외 투과를 나타낸다.3 shows the ex vivo penetration of nicotine through human body skin from a transdermal drug tour device prepared according to the method disclosed herein.

Claims (19)

대략 14내지 18시간동안 경피적으로 및 계속적으로 사람환자에게 약제를 투여하기 의한 경피약제투여장치에 있어서, 이 장치는 적층복합물로 이루어지고, 이 복합물은 (a) 실질적으로 약제에 불투과성이고 장치의 상부면을 정의하는 지지층; (b) 약제에 투과성이 있고 사람환자의 피부에 부착되는 장치의 기저면을 정의하는, 제약학적으로 허용가능한 압력-민감성 접촉접착제층으로 이루어지고, 약제가 접착제 전체에 걸쳐서 분산되고, 환자와의 접촉 14내지 18시간후에는 환자에 대한 니코틴의 효과를 무시할 수 있는 속도까지 환자에의 약제투여가 느려지는 정도로 약제를 고갈시킬 농도로 약제가 존재하는 것을 특징으로 하는 경피약제투여장치.In a transdermal drug administration device by administering a medicament to a human patient percutaneously and continuously for about 14 to 18 hours, the device consists of a layered composite, the complex being (a) substantially impermeable to the medicament and A support layer defining an upper surface; (b) a pharmaceutically acceptable pressure-sensitive contact adhesive layer, which is permeable to the medicament and defines the base of the device that is attached to the skin of a human patient, wherein the medicament is dispersed throughout the adhesive and in contact with the patient A transdermal drug administration device, characterized in that the drug is present at a concentration that will deplete the drug to a rate that can slow the drug administration to the patient after 14 to 18 hours to ignore the effect of nicotine on the patient. 제1항에 있어서, 약제가 니코틴인 것을 특징으로 하는 장치.The device of claim 1, wherein the medicament is nicotine. 제2항에 있어서, 니코틴은 0.70내지 약 1.15㎎/㎠의 범위의 양으로 접착제속에 분산되는 것을 특징으로 하는 장치.The device of claim 2, wherein the nicotine is dispersed in the adhesive in an amount ranging from 0.70 to about 1.15 mg / cm 2. 제3항에 있어서, 니코틴은 0.75내지 약 0.95㎎/㎠의 범위의 양으로 접착제속에 분산되는 것을 특징으로 하는 장치.The device of claim 3, wherein the nicotine is dispersed in the adhesive in an amount ranging from 0.75 to about 0.95 mg / cm 2. 제4항에 있어서, 니코틴은 약 0.83㎎/㎠의 양으로 접착제속에 분산되는 것을 특징으로 하는 장치.The device of claim 4, wherein nicotine is dispersed in the adhesive in an amount of about 0.83 mg / cm 2. 제1항에 있어서, 약제는 니코틴이고, 니코틴은 대략 16시간동안 계속적으로 투여되고, 니코틴은 약 0.75 내지 0.95㎎/㎠의 범위의 양으로 접착제속에 분산되는 것을 특징으로 하는 장치.The device of claim 1, wherein the medicament is nicotine, nicotine is continuously administered for approximately 16 hours, and nicotine is dispersed in the adhesive in an amount in the range of about 0.75 to 0.95 mg / cm 2. 대략 14내지 18시간동안 경피적으로 및 계속적으로 사람환자에게 니코틴을 투여하기 의한 경피약제투여장치에 있어서, 이 장치는 적층복합물의 형태이고, 이 복합물은 (a) 실질적으로 니코틴에 불투과성이고 장치의 상부면을 정의하는 지지층; (b) 지지층에 인접하고 거기에 적층된 고정접착제층; (c) 니코틴에 투과성이 있고 피부에 부착되는 장치의 기저면을 정의하는, 제약학적으로 허용가능한 압력-민감성 접촉접착제층; 및 (d) (b) 층 및 (c)층과 접촉하고, (b)층과 (c)층 사이에 포함된 투과성 흡착제 공급원 층으로 이루어지고, 니코틴은 상기의 접촉접착제층 전체에 걸쳐서 분산되고, 환자와의 접촉 14내지 18시간 후에는 환자에 대한 니코틴의 효과를 무시할 수 있는 속도까지 환자에의 니코틴 투여가 느려지는 정도로 장치내의 니코틴을 고갈시킬 범위의 로딩으로 적층복합물내에서 니코틴이 존재하는 것을 특징으로 하는 경피약제투여장치.In the transdermal drug administration device by administering nicotine to a human patient percutaneously and continuously for about 14 to 18 hours, the device is in the form of a laminated composite, which complex is (a) substantially impermeable to nicotine and A support layer defining an upper surface; (b) a stationary adhesive layer adjacent and laminated thereon; (c) a pharmaceutically acceptable pressure-sensitive contact adhesive layer that is permeable to nicotine and defines the base of the device to be attached to the skin; And (d) contacting layers (b) and (c), the permeable adsorbent source layer comprised between layers (b) and (c), wherein nicotine is dispersed throughout the contact adhesive layer After 14 to 18 hours of contact with the patient, nicotine is present in the lamination complex with a loading that will deplete nicotine in the device to such an extent that nicotine administration to the patient is slowed down to a rate that can neglect the effect of nicotine on the patient. Transdermal drug administration device, characterized in that. 제7항에 있어서, 니코틴은 약 0.75 내지 약 0.95㎎/㎠의 범위의 양으로 압력-민감성 접착제속에 존재하고 약 16시간동안 계속적으로 투여되는 것을 특징으로 하는 장치.The device of claim 7, wherein the nicotine is present in the pressure-sensitive adhesive in an amount in the range of about 0.75 to about 0.95 mg / cm 2 and continuously administered for about 16 hours. 제7항에 있어서, 니코틴이 니코틴 유리염기의 형태로 존재하는 것을 특징으로 하는 장치.8. The device of claim 7, wherein the nicotine is in the form of a nicotine free base. 제7항에 있어서, 니코틴이 염으로 존재하는 것을 특징으로 하는 장치.8. The device of claim 7, wherein nicotine is present as a salt. 제10항에 있어서, 니코틴염이 니코틴 모노아세데이트인 것을 특징으로 하는 장치.The device of claim 10, wherein the nicotine salt is nicotine monoacetate. 제7항에 있어서, 점촉접착제층 및 고정접착제층이 실질적으로 니코틴에 투과성이 있는 것을 특징으로 하는 장치.8. The device of claim 7, wherein the adhesive and pinned adhesive layers are substantially permeable to nicotine. 제7항에 있어서, 고정접착제층이 폴리이소부틸렌으로 이루어진 것을 특징으로 하는 장치.8. An apparatus according to claim 7, wherein the fixed adhesive layer is made of polyisobutylene. 제7항에 있어서, 고정접착제층이 폴리이소부틸렌과 폴리부텐의 혼합물로 이루어진 것을 특징으로 하는 장치.8. The device of claim 7, wherein the fixed adhesive layer is comprised of a mixture of polyisobutylene and polybutene. 제7항에 있어서, 접촉접착제층이 폴리이소부틸렌으로 이루어진 것을 특징으로 하는 장치.8. An apparatus according to claim 7, wherein the contact adhesive layer is made of polyisobutylene. 제7항에 있어서, 접촉접착제층이 폴리이소부틸렌과 폴리부텐의 혼합물로 이루어진 것을 특징으로 하는 장치.8. A device according to claim 7, wherein the contact adhesive layer consists of a mixture of polyisobutylene and polybutene. 제7항에 있어서, 공급원층이 부직포로 이루어진 것을 특징으로 하는 장치.8. The apparatus of claim 7, wherein the source layer consists of a nonwoven fabric. 제8항에 있어서, 부직포는 폴리에스테르로 이루어진 것을 특징으로 하는 장치.9. An apparatus according to claim 8, wherein the nonwoven is made of polyester. 대략 16시간동안 경피적으로 및 계속적으로 사람환자에게 니코틴을 투여하기 위한 경피약제투여장치에 있어서, 이 장치는 적층복합물의 형태이고, 이 복합물은 (a) 실질적으로 약제에 불투과성이고 장치의 상부면을 정의하는 지지층; (b) 지지층에 인접하고 거기에 적층된 고정접착제층으로서, 폴리이소부틸렌 및 폴리이소부틸렌과 폴리부텐의 혼합물로 구성되는 군으로 부터 선택되는 조성물로 이루어지는 고정접착제층; (c) 피부에 부착되는 장치의 기저면을 정의하는, 제약학적으로 허용가능한 압력-민감성 접촉접착제층; 및 (d) (b)층 및 (c)층과 접촉하고, (b)층과 (c)층 사이에 포함된 흡착제 부직포층으르 이루어지고, 니코틴은 니코틴 유리염기 및 니코틴 모노아세테이트로 구성되는 군으로부터 선택되고, 상기의 접촉접착제층 전체에 걸쳐서 분산되고, 환자와의 접촉 16시간후에는 환자에 대한 니코틴의 효과를 무시할 수 있는 속도까지 환자에의 니코틴 투여가 느려지는 정도로 장지내의 니코틴을 고갈시킬 범위의 로딩으로 적층복합물내에서 니코틴이 존재하는 것을 특징으로 하는 경피약제투여장치.In a transdermal drug administration device for administering nicotine to a human patient percutaneously and continuously for approximately 16 hours, the device is in the form of a layered composite, the complex being (a) substantially impermeable to the drug and having an upper surface of the device. A support layer defining a; (b) a fixed adhesive layer adjacent and laminated thereon, the fixed adhesive layer comprising a composition selected from the group consisting of polyisobutylene and a mixture of polyisobutylene and polybutene; (c) a pharmaceutically acceptable pressure-sensitive contact adhesive layer that defines the base surface of the device attached to the skin; And (d) an adsorbent nonwoven layer in contact with layers (b) and (c), the adsorbent nonwoven layer comprised between layers (b) and (c), wherein nicotine is composed of nicotine free base and nicotine monoacetate. Is dispersed throughout the contact adhesive layer and depletes nicotine in the intestinal tract to such a degree that nicotine administration to the patient is slowed down to a rate that can neglect the effects of nicotine on the patient after 16 hours of contact with the patient. A transdermal drug administration device, characterized in that nicotine is present in the laminate composite at a range of loadings. ※ 참고사항 : 최초출원 내용에 의하여 공개하는 것임.※ Note: The disclosure is based on the initial application.
KR1019950700729A 1992-08-25 1992-12-10 Printed Transdermal Drug Delivery Device KR950702811A (en)

Applications Claiming Priority (3)

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US93504492A 1992-08-25 1992-08-25
US07/935044 1992-08-25
PCT/US1992/010672 WO1994004109A1 (en) 1992-08-25 1992-12-10 Printed transdermal drug delivery device

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KR950702811A true KR950702811A (en) 1995-08-23

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KR (1) KR950702811A (en)
AU (1) AU3247193A (en)
CA (1) CA2142871A1 (en)
FI (1) FI950766A (en)
NO (1) NO950725L (en)
WO (1) WO1994004109A1 (en)

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NO950725D0 (en) 1995-02-24
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FI950766A0 (en) 1995-02-20
JPH08502727A (en) 1996-03-26

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